Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices

The TGA sought feedback on the draft guidance Complying with the Unique Device Identification regulations for medical devices. The consultation principally sought feedback on:

• Relevance of the content
• Usability of the content
• Structure of the document
• Terminology used in the document
• Additional content that would benefit the reader. 

37 submissions were received, with most representing medical device sponsors and manufacturers. Other respondents includes industry peak bodies, registries, regulatory consultants and Issuing Agencies. No submissions were received from general practitioners, export-only Australian manufacturers, or consumers. 

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses provided positive feedback on the document as well as many valuable comments and suggests for improving the usability and content of the document.

The TGA appreciates all the feedback and thanks all respondents. 

We have analysed all responses and the results have informed updates to the guidance document. In line with your strong feedback, changes made to the document include:

• Additional examples, use cases and images
• Further explanation for complex topics such as UDI Triggers and Unit of Use
• Additional appendices including Australian UDI Data Elements
• Inclusion of additional information for topics such as:
  • Medical devices incorporating software
  • Refurbished devices
  • Devices sold principally in retail premises
  • Capital equipment
  • In vitro diagnostic kits
  • Record keeping requirements
  • Single use devices
  • Spare parts, replacement parts and accessories
• Editorial changes. 

The guidance will be published on the UDI Hub on the TGA website once finalised.